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临床试验/NCT03434925
NCT03434925Unknown不适用

Development of a New Generation Multi Parametric Test for Prediction of Colorectal Neoplasia Recurrence

Military University Hospital, Prague1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Presence of genetic markers for local recurence after resection of colorectal neoplasia

研究概览

简要总结

This project is dedicated to identify the patients with possible higher risk of adenoma recurrence who should have follow-up colonoscopy in yearly interval. As a result, it can lead to optimizing the of follow-up colonoscopies intervals in real-world practice.

详细描述

In this project, 200 individuals (aged 18 - 75 years) with removed colorectal polyps larger than 10 mm during colonoscopy performed based on all indication (including symptoms and screening procedures) will be included. All procedures will be done with high quality endoscopes (high definition, HD).

In all polyps, the advanced imaging techniques (such as chromoendoscopy and NBI) will be used to determine parts of the polyp suspicious from high-grade dysplasia or cancer. The therapeutic method will be decided by the size and macroscopic appearance of the polyp. In case of flat, sessile polyps and LST lesions (laterally spreading tumors) EMR or ESD will be performed. Pedunculated polyp will be removed by EPE. The goal is to achieve the en-bloc resection. Pathologists (with presence of the endoscopist) will do the first step of histopathology evaluation (cutting the polyp tissue). The aim is to perform the first cut in the most advanced part of the polyp and high density cutting in this area. Standard histopathology evaluation will proceed and will be followed by initial basic molecular testing.

Subsequently, all patients will be observed by colonoscopy in one-year intervals with focus on polyp recurrence. The group of high-risk patients will be selected with at least one of these criteria: 1/ high grade dysplasia adenoma at index colonoscopy; 2/ high score of polyp heterogenity at index colonoscopy; 3/ polyps recurrence at follow-up colonoscopy.

In a high-risk patients group the extensive somatic mutations profiling will be carried out according to multitarget sequencing by NGS technologies (next generation sequencing). Same testing will be done in randomly selected patients not included in the high-risk group, which will be used as a control group for statistical evaluation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
  • •Signed informed consent with the study and with colonoscopy

排除标准

  • •FAP, HNPCC and other hereditary CRC syndromes probands
  • •Recent diagnostic, follow-up or preventive colonoscopy (FOBT-positive colonoscopy, screening colonoscopy) in ≤ 3 years
  • •Colonoscopy contraindication
  • •Severe acute inflammatory bowel disease
  • •Severe comorbidities; likely non-compliance of the patient

结局指标

主要结局

Presence of genetic markers for local recurence after resection of colorectal neoplasia

时间窗: 3 years

Measurement of gene mutations associated with local recurrence of advanced colorectal neoplasia after endoscopic resection.

次要结局

  • Risk of polyp recurrence(3 years)
  • Topographic heterogenity of polyps(3 years)

研究者

发起方
Military University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stepan Suchanek, MD., Ph.D.

MD., Ph.D.

Military University Hospital, Prague

研究点 (1)

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